Overview

Bioequivalence Study of Two Formulations of Febuxostat 120 mg Film-coated Tablets in Healthy Adult Volunteers After a Single Oral Dose Administration Under Fasting Conditions

Status:
Completed

Trial end date:
2019-06-06

Target enrollment:

Participant gender:

Summary

This study is designed in accordance with the European Medicines Agency (EMA) regulatory guidelines, with the aim of characterizing the bioavailability of febuxostat in the two formulations in healthy adult subjects. Within the clinical portion of the study each subject will receive a single oral dose of the test and the reference formulation in compliance with the generated randomization code. The primary study endpoints are the pharmacokinetic (PK) parameters Cmax and AUC0-T of febuxostat.

Phase:

Phase 1

Details

Lead Sponsor:

Pharmtechnology LLC

Collaborators:

Altasciences Company Inc.
Altasciences Company, Inc.

Treatments:

Febuxostat